A Clinical Evaluation of Omron Digital Blood Pressure Monitor

A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03130686

Enrollment

Registered

2017-04-26

Start date

2015-12-21

Completion date

2016-03-31

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

Interventions

DEVICEOMRON blood pressure monitor HEM-9210T

To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Upper arm circumference: 17-50cm

Exclusion criteria

* Patients who has arrhythmia. * When body motion is observed during measurement. * Korotkoff sound is poor quality. * Patient's arm circumference is outside cuff range. * Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg. * Patients stated they did not wish to continue with the study and it is stopped before completion.

Design outcomes

Primary

Measure	Time frame	Description
Verify the accuracy of measure functions of device	30 days	The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026